System, Image Processing, Radiological
FDA adverse event reports and recall history for system, image processing, radiological (product code LLZ), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 19,970
- Deaths
- 41
- Injuries
- 124
- Malfunctions
- 19,692
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2026-09-15Open, ClassifiedUnder Investigation by firm
Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.
- 2026-09-15Open, ClassifiedUnder Investigation by firm
Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.
- 2026-09-15Open, ClassifiedUnder Investigation by firm
Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices, All versions
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.
- 2026-09-15Open, ClassifiedUnder Investigation by firm
Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.
- 2026-09-15Open, ClassifiedUnder Investigation by firm
Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Administration, common configuration management for consuming applications, All versions
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.
- 2026-09-15Open, ClassifiedUnder Investigation by firm
Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise imaging workflows, All versions
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.
- 2026-08-26Open, ClassifiedSoftware design
FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Software issue may cause the ruler measurement to be inaccurate.
- 2026-08-21Open, ClassifiedSoftware Design Change
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Software issue may cause measurements to be displayed inaccurately.
- 2026-08-04Open, ClassifiedSoftware Design Change
Merge PACS, medical imaging diagnostic workstation
Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open.
- 2026-08-04Open, ClassifiedSoftware Design Change
Merge OrthoPACS, medical imaging diagnostic workstation
Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open.
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